ANTIDEPRESSANT: Pre-Med Student Stabs Fellow Students, One Dead, 3 Injured

Kendrex White, 21 year old pre-med student charged with murder for stabbing death at the University of Texas, Austin
Yet another drugged up future medical professional! Cannot count how many cases like this I have investigated over the past three decades! Who knows how many the world will have to witness before they finally wake up to this medication induced nightmare! You can see all of the details on this case in the link to the news story at the bottom of this post. You will learn he was arrested before for a DUI (and hopefully you know enough about antidepressants to know they cause cravings for alcohol and you can find all that documentation here on our site or in mor detail in my book on the drugs, Prozac: Panacea or Pandora? Our Serotonin Nightmare!). When he was arrested then he said he had taken two pills of Zoloft. So what is he on now? Obviously he is experiencing the side effect of “homicidal ideation” which I would refer you to the post below where I have another patient who explains the reality of what homicidal ideation was for him after only two Zoloft – the same thing this fellow said he took.
Nurses have been telling me for years that 75% of doctors and nurses are on these drugs. And I hear repeatedly from doctors whose cases I have worked that the drugging started in medical school and continues for years into their careers. Those who peddle illegal drugs on street corners are in similar positions with those selling the drugs hooked on them also. Sadly there is apparently little difference rather than the one is a “respected professional” drug pusher and the other the guy on the street corner. Is it any wonder that NPR reported several years ago that 60% of cases of violence are happening in medical establishments?
Take a look at my post from a few weeks ago to see what just two pills of Zoloft can do and ask what this guy is on now…still Zoloft or just another brand of the same antidepressant drugs so similar to PCP?

“Homicidal Ideation” Described by Patient Who Suffered

This Antidepressant-Induced Side Effect

“Only two days on Zoloft and I wanted death bad – I wanted death like I wanted a new Ferrari…

but I wanted it not just for me, but for everyone!!!”

“I am a veteran of 15 years. I have seen the disasters from prescription medications especially the ones we were issued to treat PTSD and other mental illnesses. A couple of years ago, I agreed to take Zoloft as suggested by my doctor for depression. I had denied it for years.

“Within 2 days I waas truly suicidal. I wanted death bad. It wasn’t like the normal suicidal thoughts where I felt so depressed I would rather be dead, it was more like I wanted death like I wanted a new Ferrari. But not just for me, I wanted it for everyone! I wanted to get my friends together and thought let’s all die together. I have been confused by how this drug can make you feel this way. I certainly felt why so many commit suicide on these drugs and why it is a listed side effect! I tried to OD, but I sucked at it fortunately. I never touched another pill again.

ORIGINAL ARTICLE: http://heavy.com/news/2017/05/kendrex-kendrix-white-university-texas-austin-stabbing-suspect-attacker-photos-pictures-facebook-twitter-motive/

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Two School Shootings in the News on Columbine’s 18th Anniversary

Today, Thursday, April 20, 2017, marks the 18th anniversary of the mass shooting at Columbine High School in Littleton, Colorado and marks the day after Barry Loukitis, in one of the first school shootings in this country, was once again given 189 years for killing a teacher and two classmates in Moses Lake, WA while no mention of these drugs and the role they played in that case has ever been mentioned in his defense! And while the real guilty parties in these school shootings continue to live in plush luxury with no repercussions whatsoever to this day!

The 12 students listed below and one teacher, William “Dave” Sanders, 47, were killed during the attack on the morning of April 20, 1999. And Eric Harris and Dylan Kleebold lost their lives in either a double suicide or a murder/suicide after the attack. Today we remember all the lives that were lost that day as well as those were severely injured and those whose lives were changed forever when Eric and Dylan reacted to their antidepressants:

Cassie Bernall, 17
Steven Curnow, 14
Corey DePooter, 17
Kelly Fleming, 16
Matthew Kechter, 16
Daniel Mauser, 15
Daniel Rohrbough, 15
Rachel Scott, 17
Isaiah Shoels, 18
John Tomlin, 16
Lauren Townsend, 18
Kyle Velasquez, 16

The day this happened I was on the phone with Ruben Ortega, Chief of Police in Salt Lake City, discussing with him some local tragedies to help him to understand the impact of these drugs upon the community he served and the public as a whole. The Salt Lake Family History Library shooting had recently happened with an elderly Russian man killing two before being shot. That elderly Russian man had an experience very similar to the German Wings pilot who two years ago took a plane with 150 to their deaths as he flew it into a mountain side in the Alps. This elderly Russian man noticed that he was losing his eyesight as a result of his antidepressant so he just stopped taking it with NO IDEA what that can cause! (If you see the REM Sleep Disorder listed in the Evidence section on School Shootings you will see the reaction he had that morning on his daily walk past the Family History Library as he opened fire killing one of my dear friends, Don Thomas, whom I had warned over and over again about the danger he was in there as the Family History Library security guard.) As Chief Ortega learned more and more about how these drugs work and how they can produce psychosis and violence and are so very similar in action to a slow fuse LSD or PCP he mentioned that was the case in the recent KSL shooting as well. The woman who came into that building shooting and killing a woman who worked there and her unborn child was also on one of these drugs. He then asked me, “Do you think what is going on right now in that school shooting in Littleton, CO could be caused by these drugs as well?” I replied that I did not generally see a case where two people go off the deep end on these drugs at the same time, but if they commit suicide too, you can bet it is one of these cases.” I was to later learn that about the same time I was making that statement to Chief Ortega is when Eric and Dylan lost their lives to the suicidal ideation we now have warnings are doubled for those under the age of 25 who take these drugs.

Mark Taylor’s Fight for Columbine

Please watch Mark Taylor’s Fight For Columbine to see how this tragedy has never gone away for Mark and has only gotten worse for him after he filed suit against the antidepressant maker of Luvox . Luvox is the antidepressant Eric Harris was taking when he shot Mark. And before anyone starts in on we don’t have any evidence of Dylan being on anything you need to know  that a girlfriend of Dylan’s came to Mark Taylor’s mother and then spoke with me about trying to help Dylan come off his Zoloft and Paxil (the same drug found guilty in the suicide of one of the nations’ leading attorneys.

http://www.drugawareness.org/mark-taylors-fight4columbine/

Now Take a Look at the Massive Amount of Evidence that Antidepressants are the Cause of School Shootings

 

SCHOOL SHOOTINGS: The Evidence Antidepressants Are The Cause

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ANTIDEPRESSANTS??? FATHER KILLS WIFE AND SELF IN FRONT OF CHILDREN IN HOUSTON

080615-ktrk-murder-suicide-02

Suicidal Father Shoots Wife and Self in Front of Children

Thank you to the doctor’s wife who sent this case in their own area this morning…

Everyone should know that antidepressants are almost always the common denominator in murder/suicides any more. In tracking these cases for 25 years I rarely find a murder/suicide that does not involve these drugs.

Doctors give them couples antidepressants because they are naturally depressed over the breakup of their family and this is far too often the end result. Note that the father was first suicidal and then turned the gun on his wife and then himself while obviously suffering both suicidal ideation and homicidal ideation.

Remember before these drugs when depressed people used to go off alone to kill themselves rather than taking loved ones with them?

View the news report here: 

http://abc13.com/news/police-kids-witness-parents-murder-suicide/905959/

The drugs are known to cause paranoia, aggression and violence which can easily lead to a divorce as well. So the drugs could have produced the separation to begin with. The question always needs to be asked for the sake of the children left behind.

I have testified in these cases for almost 25 years (comedian Phil Hartman and his wife were the most high profile case). Their children deserved to know the truth about how they lost their parents!

Deadly drugs! Here are 5000 other examples of the violence they produce:

www.SSRIstories.NET

EXCESS SEROTONIN PRODUCES EXTREME VIOLENCE

What so many were not aware of is that an increase in serotonin by an accompanying decrease in one’s ability to metabolize serotonin was long known to produce both impulsive murder and suicide. See this study out of the Southern California:

http://www.drugawareness.org/mutant-mice-key-to-human-violence-an-excess-serotonin/

ANTIDEPRESSANTS PRODUCE SLEEP DISORDER KNOWN TO

INCLUDE BOTH MURDER AND SUICIDE

What the world remains unaware of is the fact is that 86% of those who are diagnosed with the most deadly sleep disorder known as REM Sleep Disorder (RBD) are currently taking antidepressants. REM Sleep Disorder is a condition in which there is no paralysis during sleep thus allowing the patient to act out the dreams or nightmares they are having. Tragically 80% of those going into this sleep disorder hurt themselves or others including both murder and suicide as a result.

This is possibly the most deadly of all reactions one can have to antidepressants. Even more frightening though is to learn that before the introduction of the SSRI antidepressants RBD was known mainly as a drug withdrawal effect. Thus the chances of going into this dangerous reaction should be expected to increase as one goes into withdrawal. This is why it is so important to avoid as much of the withdrawal effects as possible by tapering off the antidepressant very, very slowly.

Ann Blake Tracy, Executive Director,

International Coalition for Drug Awareness

drugawareness.org & ssristories.NET
Author: ”Prozac: Panacea or Pandora? – Our Serotonin Nightmare – The Complete Truth of the Full Impact of Antidepressants Upon Us & Our World” & Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

WITHDRAWAL WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!

WITHDRAWAL HELP: You can find the hour and a half long CD on safe and effective withdrawal helps here:http://store.drugawareness.org/ And if you need additional consultations with Ann Blake-Tracy, you can book one atwww.drugawareness.org or sign up for one of the memberships in the International Coalition for Drug Awareness which includes free consultations as one of the benefits of that particular membership plan. For only a $30 membership for one month you can even get 30 days of access to the withdrawal CD with tips on rebuilding after the meds, all six of my DVDs, hundreds of radio interviews, lectures, TV interviews I have done over the years PLUS access to my book on antidepressants (500 plus pages) with more information than you will find anywhere else (that is only $5 more than the book alone would cost) atwww.drugawareness.org. (Definitely the best option to save outrageous postage charges for those out of the country!)

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1991 FDA Antidepressant Hearing: Mother Kills Two Sons & Attempts Suicide – Tucker Moneymaker

TuckerMoneymaker

On April 5, 1991, after only 21 days on Prozac Tucker Moneymaker’s wife Sandra, 36, shot and killed their two sons, David Lee, 8, and William, 16, while they slept before shooting herself twice in the abdomen in a suicide attempt. The bottle of Prozac was found in the room with them. Tucker had left for work at 7:00 AM and returned at 8:37 AM to find the boys dead and his wife bleeding and unconscious. Read below for the scientific data on how Prozac can cause murder/suicide.

Here is the video of Tucker Moneymaker testimony before the FDA hearing (FDA Psychopharmacologic Drugs Advisory Hearing) September 20, 1991:

And here is the text of Tucker Moneymaker’s testimony to the FDA on September 20, 1991:

DEPARTMENT OF HEALTH AND HUMAN SERVICES PUBLIC HEALTH SERVICE FOOD AND DRUG ADMINISTRATION

FDA Psychopharmacologic Drugs Advisory Hearings

DR. CASEY: Thank you. Tucker Moneymaker, please?

MR. MONEYMAKER: Thank you. On behalf of myself and thousands of other citizens in the states of North Carolina, Virginia, and West Virginia, of which I happen to be the Prozac Survivor Director for these three states, I want to say thank you for allowing the public to come up here and speak and voice their opinion about this dangerous drug.

I also want to tell everybody that these are real stories, real people. This is not something written down on a piece of paper, something somebody wrote up somewhere. These are real things that are happening.

My story is also real. It’s just a real nightmare, something I have to live with every day. I had two sons, David Lee, age 8, and Billy, 16, a wife of 20 years, is all gone. I’ll tell you why. In March of this year my wife, Sandra, had some nerve problems. She was asked to go be evaluated. The doctor put her on Prozac. He told her she was depressed because she was having nerve problems.

Now, I want you to keep this in mind, how my wife was, just a little short story. My wife was the kind of mother that always put the kids first. She would take her kids back and forth to school every day. My 8-year-old never rode a school bus. My wife was tied up in the church, tied up in Cub Scouts and room mother at school.

I heard these people talking about scientific data. I want to show them some scientific data. This is scientific data right here. I want you all to look at it. This is scientific data for those who say we don’t have scientific data.

I haven’t slept but about two hours since Sunday.

I want to apologize if I sound a little shaky. After being on Prozac for 21 days, my wife shot and killed both of these two boys right here. She turned the gun on herself and shot herself herself twice. Now she’s in jail for murder.

This is the kind of lady that never took a drug, no mixed drinks, no alcohol, no reason to be depressed, just some nerve problems, like everybody has from time to time. I’m depressed. I’ve got legitimate reason to be depressed. I want to ask you all, don’t let this happen to anybody else. These are real people. You know, these murders and things are senseless. It’s time to put a stop to it.

Thank you.

MOTHER INDICTED IN HALIFAX SLAYINGS: https://news.google.com/newspapers?nid=1298&dat=19910416&id=wuJNAAAAIBAJ&sjid=WosDAAAAIBAJ&pg=3958,2783944&hl=en

PERSONAL TRAGEDY SPURS CRUSADE:

https://news.google.com/newspapers?nid=1298&dat=19910805&id=Q29WAAAAIBAJ&sjid=FeQDAAAAIBAJ&pg=6879,789625&hl=en

HOW ANTIDEPRESSANTS CAN PRODUCE MURDER AND SUICIDE:

There are several ways. First of all they impair the metabolism of serotonin so that serotonin will build up in the synapse. And we were suppose to believe that was beneficial. But take a look at this research from the University of Southern California on excess serotonin producing extreme violence: http://www.drugawareness.org/mutant-mice-key-to-human-violence-an-excess-serotonin/

Another way it can be done is by inducing the REM Sleep Disorder (RBD) – a state in which one acts out nightmares and which has long been known to include both impulsive murder and suicide. At this point 86% of those being diagnosed with this disorder are taking antidepressants. Because of the time of day this case happened it would most likely be triggered by RBD.

Another way they can induce this type of violence is by chemically inducing a manic psychosis. In the beginning of the SSRI antidepressant era psychiatrists refused to prescribe Prozac due to its strong ability to induce mania/Bipolar Disorder. That is far from the case now though.

Ann Blake Tracy, Executive Director,

International Coalition for Drug Awareness

drugawareness.org & ssristories.NET
Author: ”Prozac: Panacea or Pandora? – Our Serotonin Nightmare – The Complete Truth of the Full Impact of Antidepressants Upon Us & Our World” & Withdrawal CD “Help! I Can’t Get Off My Antidepressant!”

WITHDRAWAL WARNING: In sharing this information about adverse reactions to antidepressants I always recommend that you also give reference to my CD on safe withdrawal, Help! I Can’t Get Off My Antidepressant!, so that we do not have more people dropping off these drugs too quickly – a move which I have warned from the beginning can be even more dangerous than staying on the drugs!

WITHDRAWAL HELP: You can find the hour and a half long CD on safe and effective withdrawal helps here: http://store.drugawareness.org/ And if you need additional consultations with Ann Blake-Tracy, you can book one at www.drugawareness.org or sign up for one of the memberships in the International Coalition for Drug Awareness which includes free consultations as one of the benefits of that particular membership plan. For only a $30 membership for one month you can even get 30 days of access to the withdrawal CD with tips on rebuilding after the meds, all six of my DVDs, hundreds of radio interviews, lectures, TV interviews I have done over the years PLUS access to my book on antidepressants (500 plus pages) with more information than you will find anywhere else (that is only $5 more than the book alone would cost) at www.drugawareness.org. (Definitely the best option to save outrageous postage charges for those out of the country!)

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SOLDIER “MAY HAVE GONE BERSERK” IN AFGHAN SHOOTING

Intern’tl Coalition for Drug Awareness

Message

1. SOLDIER “MAY HAVE GONE BERSERK” IN AFGHAN SHOOTING

Posted by: “Ann Blake-Tracy”

Mon Mar 12, 2012 11:39 pm (PDT)

SOLDIER “MAY HAVE GONE BERSERK” IN AFGHAN SHOOTING:

Okay things are beginning to come out about this case … SO LET’S LOOK AT THEM….

#1 Very significant is that two years ago this soldier suffered Traumatic Brain Injury. Anyone who has had a brain injury should NEVER be given an antidepressant according to neurologist, Dr. Jay Seastrunk. The brain is far more vulnerable to seizure activity after such an injury and taking a stimulant (An ANTI-depressant or the opposite of a depressant IS A STIMULANT!). Remember that a manic psychosis is a continuous series of seizures in the brain which is basically what REM Sleep is also. (Keep that in mind as you read below about REM sleep.)

#2 In this article Dr. Johnathan Shay describes what he calls Berserk: “Berserkers … have this curious quality of icy and flaming rage; all they want to do is destroy, they want nothing to get in the way of their unmediated destruction and killing, and they are truly insensitive to pain. They are totally beyond the society of their own military forces and disconnected from them.”

“It’s a painful and destructive thing and usually fatal for the soldier… The term “berserk” is an Old Norse word describing the frenzied trance in which some warriors fought.”

Now what he has just described as “berserkness” is what is a perfect description of “homicidal ideation” – a compulsion to kill – continuous thoughts of killing and continuous thoughts of methods of killing – coupled with rage. Both rage & homicidal ideation are listed side effects of antidepressants which are prescribed at a shocking rate to our military! The main drug anyone would think of producing this type of reaction is PCP (Angel Dust) & antidepressants are the most similar drugs in action to PCP the world has ever seen!!

#3 Another quote from this article states: “And sleep is unmistakably the fuel for the frontal lobes of the brain, and when you’re out of gas in the frontal lobe you become a moral moron — a catastrophe with no moral restraint.” Combat stress, or PTSD in its most virulent form, tends to disrupt sleep.”

PTSD in its most virulent form does disrupt sleep but what disrupts sleep even more is antidepressants. One of the first things noted about the first SSRI antidepressant on the market, Prozac, was how it repressed REM Sleep. Now for those of you who have read my book, Prozac: Panacea or Pandora? – Our Serotonin Nightmare, know after reading the chapter on the REM Sleep Behavior Disorder (RBD) that antidepressants cause this disorder where you act out nightmares. More recent research demonstrates that 86% of those being diagnosed with RBD are currently taking an antidepressant even though it has mainly been known as a drug withdrawal state. So those in withdrawal have an even greater chance of going into this sleepwalk nightmare we call RBD!

Close friends of mine had a son leave for Iraq a couple of years ago. The young man called his father, a social worker, to ask about taking an antidepressant. Why? Because he was told by Army personnel that he would need one in order to go to Iraq! Knowing a little about my work after learning a close friend of his was stabbed, along with his mother & sister, by their father, who then shot himself after only five days on Zoloft, he was concerned about antidepressants. A veteran himself, his father’s response was level headed. He told his son that if he ever needed to have his thoughts together & control over his actions & NOT be under the influence of a mind altering drug it would be while carrying a gun & facing what he would in Iraq.

Now what was most alarming to me was that so much pressure had been put on this young man by his superiors to take these drugs that even after all he had witnessed in his own personal life they had pushed him to the point that he would even feel like he needed to ask his father this question!!! Clearly our troops are being pressured into taking these drugs & have been drugged out of their minds for many years now – even to the point of this is the first war in which we are losing more troops to suicide than combat!!

I urge you to share this information with local reporters & everyone you know as a warning of the most deadly aspects of these drugs we mistakenly call “antidepressants”! Send them to read my FDA presentations how how these drugs can produce such violence at www.drugawareness.org (located just under the picture of my book on the right side) & to our database of cases like this one at www.ssristories.drugawareness.org so they can see the evidence that does exist & is presented in courtrooms in these cases. None of this should remain hidden from the public because this is a public safety issue!!!

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
www.drugawareness.org & www.ssristories.drugawareness.org
Author: “Prozac: Panacea or Pandora? – Our Serotonin Nightmare –
The Complete Truth of the Full Impact of Antidepressants Upon
Us & Our World” & CD on Safe Withdrawal “Help! I Can’t Get Off My Antidepressant!”

 

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NEJM: On Zoloft Homicidal Ideation Frequent In Those 17 & Under

Since I believe that people should always get credit for the hard work and contribution they make in life I want to give our thanks to Rosie Meysenburg for getting this out to us today and for her comments on it. Rosie has done so much, along with her husband Gene, in posting our years and years worth of work gathering these SSRI & SNRI cases together for the _www.ssristories.drugawareness.org_
(http://www.ssristories.drugawareness.org) site.

“This Adverse Event Report, from a study appearing in the New England Journal of Medicine, shows that of 133 children 17 & under on Zoloft there were 2 who reported “Homicidal Ideation”. There were no reports of “Homicidal Ideation” in the placebo group.

[According to the Physicians Desk Reference, a Frequent adverse reaction is one that occurs in 100 people or less.  Homicidal Ideation occurred in 1 in 66 children on Zoloft aged 17  and under.]

“According to the Physicians Desk Reference, a Frequent adverse reaction is one that occurs in 100 people or less. Homicidal Ideation occurred in 1 in 66 children on Zoloft aged 17 and under.

“This Adverse Event Report was the appendix for this study in the New England Journal of Medicine.”

adverse event report1.pdf

This Adverse Event Report was the appendix for this study in the New England Journal of Medicine:

http://content.nejm.org/cgi/content/full/NEJMoa0804633

And with this new information from the New England Journal of Medicine I want to include information out of Australia which is that Pfizer, the maker of Zoloft, along with the Therapeutic Goods Administration (TGA similar to our FDA), recommends that any SSRI antidepressant should not be prescribed to Australians under the age of 24. Funny, but I missed that warning from Pfizer for Americans under 24, didn’t you?

Next I will send that article that just came out over the weekend because it ties in so closely with this new information on Zoloft. And because there is so much to read in this article alone I am going to cut my comments at this point and let the article speak for itself.

Ann Blake-Tracy, Executive Director,
International Coalition for Drug Awareness
_www.drugawareness.org_ (http://www.drugawareness.org/) &
_www.ssristories.org_ (http://www.ssristories.org/)
Author of Prozac: Panacea or Pandora? – Our
Serotonin Nightmare & the audio, Help! I Can’t
Get Off My Antidepressant!!! ()

_atracyphd1@…_ (mailto:atracyphd1@…)

_http://content.nejm.org/cgi/content/full/NEJMoa0804633_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633)

Published at www.nejm.org October 30, 2008 (10.1056/NEJMoa0804633)
Cognitive Behavioral Therapy, Sertraline, or a Combination in Childhood
Anxiety

John T. Walkup, M.D., Anne Marie Albano, Ph.D., John Piacentini, Ph.D.,
Boris Birmaher, M.D., Scott N. Compton, Ph.D., Joel T. Sherrill, Ph.D., Golda
S. Ginsburg, Ph.D., Moira A. Rynn, M.D., James McCracken, M.D., Bruce Waslick,
M.D., Satish Iyengar, Ph.D., John S. March, M.D., M.P.H., and Philip C. Kendall, Ph.D.

ABSTRACT
Background Anxiety disorders are common psychiatric conditions affecting children and adolescents. Although cognitive behavioral therapy and selective serotonin-reuptake inhibitors have shown efficacy in treating these disorders, little is known about their relative or combined efficacy.

Methods In this randomized, controlled trial, we assigned 488 children between the ages of 7 and 17 years who had a primary diagnosis of separation anxiety disorder, generalized anxiety disorder, or social phobia to receive 14 sessions of cognitive behavioral therapy, sertraline (at a dose of up to 200 mg per day), a combination of sertraline and cognitive behavioral therapy, or a placebo drug for 12 weeks in a 2:2:2:1 ratio. We administered categorical and dimensional ratings of anxiety severity and impairment at baseline and at
weeks 4, 8, and 12.

Results The percentages of children who were rated as very much or much improved on the Clinician Global Impression “Improvement scale were 80.7% for combination therapy (P<0.001), 59.7% for cognitive behavioral therapy (P<0.001), and 54.9% for sertraline (P<0.001); all therapies were superior to placebo
(23.7%). Combination therapy was superior to both monotherapies (P<0.001).

Results on the Pediatric Anxiety Rating Scale documented a similar magnitude and pattern of response; combination therapy had a greater response than cognitive behavioral therapy, which was equivalent to sertraline, and all therapies were superior to placebo. Adverse events, including suicidal and homicidal
ideation, were no more frequent in the sertraline group than in the placebo group. No child attempted suicide. There was less insomnia, fatigue, sedation, and restlessness associated with cognitive behavioral therapy than with sertraline.

Conclusions
Both cognitive behavioral therapy and sertraline reduced the severity of anxiety in children with anxiety disorders; a combination of the two therapies had a superior response rate.

(ClinicalTrials.gov number,
NCT00052078 _[ClinicalTrials.gov]_
(http://content.nejm.org/cgi/external_ref?access_num=NCT00052078&link_type=CLINT\
RIALGOV
) .)

____________________________________
Anxiety disorders are common in children and cause substantial impairment in
school, in family relationships, and in social functioning._1_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R1) ,_2_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R2) Such disorders
also predict adult anxiety disorders and major depression._3_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R3) ,_4_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R4) ,_5_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R5) ,_6_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R6) Despite a high
prevalence (10 to 20%_3_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R3)
,_7_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R7) ,_8_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R8) ) and substantial
morbidity, anxiety disorders in childhood remain underrecognized and
undertreated._1_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R1)
,_9_

(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R9)

An improvement in outcomes for children with anxiety disorders would have important public health
implications.In clinical trials, separation and generalized anxiety disorders and social
phobia are often grouped together because of the high degree of overlap in
symptoms and the distinction from other anxiety disorders (e.g., obsessive compulsive disorder). Efficacious treatments for these disorders include cognitive behavioral therapy_10_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R10) ,_11_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R11) and
the use of selective serotonin-reuptake inhibitors (SSRIs)._12_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R12) ,_13_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R13)

However, randomized, controlled trials comparing cognitive behavioral therapy, the use of an SSRI, or the combination of both therapies with a control are lacking. The evaluation of combination therapy is particularly important because approximately 40 to 50% of children with these disorders do not have a response to short-term treatment with either monotherapy.
_14_(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R14) ,_15_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R15)

Our study, called the Child “Adolescent Anxiety Multimodal Study, was designed to address the current gaps in the treatment literature by evaluating the relative efficacy of cognitive behavioral therapy, sertraline, a combination of the two therapies, and a placebo drug. This article reports the results of short-term treatment.

Methods

Study Design and Implementation

This study was designed as a two-phase, multicenter, randomized, controlled trial for children and adolescents between the ages of 7 and 17 years who had separation or generalized anxiety disorder or social phobia. Phase 1 was a 12-week trial of short-term treatment comparing cognitive behavioral therapy, sertraline, and their combination with a placebo drug. Phase 2 is a 6-month open extension for patients who had a response in phase 1.

The authors designed the study, wrote the manuscript, and vouch for the data gathering and analysis. Pfizer provided sertraline and matching placebo free of charge but was not involved in the design or implementation of the study, the analysis or interpretation of data, the preparation or review of the manuscript, or the decision to publish the results of the study.

Study Subjects

Children between the ages of 7 and 17 years with a primary diagnosis of separation or generalized anxiety disorder or social phobia (according to the criteria of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition, text revision
[DSM-IV-TR]_16_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R16) ),
substantial impairment, and an IQ of 80 or more were eligible to participate. Children with coexisting psychiatric diagnoses of lesser severity than the three target disorders were also allowed to participate;
such diagnoses included attention deficit–hyperactivity disorder (ADHD) whilereceiving stable doses of stimulant and obsessive compulsive, post-traumatic stress, oppositional defiant, and conduct disorders. Children were excluded if they had an unstable medical condition, were refusing to attend school
because of anxiety, or had not had a response to two adequate trials of SSRIs or an adequate trial of cognitive behavioral therapy.

Girls who were pregnant or were sexually active and were not using an effective method of birth control
were also excluded. Children who were receiving psychoactive medications other than stable doses of stimulants and who had psychiatric diagnoses that made participation in the study clinically inappropriate (i.e., current majordepressive or substance-use disorder; type ADHD; or a lifetime history of bipolar, psychotic, or pervasive developmental disorders) or who presented an acute risk to themselves or others were also excluded.

Recruitment occurred from December 2002 through May 2007 at Duke University Medical Center, New York State Psychiatric Institute Columbia University Medical Center New York University, Johns Hopkins Medical Institutions, Temple University University of Pennsylvania, University of California, Los Angeles,and
Western Psychiatric Institute and Clinic University of Pittsburgh Medical Center. The protocol was approved and monitored by institutional review boards at each center and by the data and safety monitoring board of the National Institute of Mental Health. Subjects and at least one parent provided written informed consent.

Interventions

Cognitive behavioral therapy involved fourteen 60-minute sessions, which included review and ratings of the severity of subjects’ anxiety, response to treatment, and adverse events. Therapy was based on the Coping Cat program,_17_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R17) ,_18_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R18) which was adapted for the
subjects’ age and the duration of the study._19_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R19)

Each subject who was assigned to receive cognitive behavioral therapy received training in anxiety-management skills, followed by behavioral exposure to anxiety-provoking situations. Parents
attended weekly check-ins and two parent-only sessions. Experienced psychotherapists, certified in the Coping Cat protocol, received regular site-level and cross-site supervision.

Pharmacotherapy involved eight sessions of 30 to 60 minutes each that included review and ratings of the severity of subjects’ anxiety, their response to treatment, and adverse events. Sertraline (Zoloft) and matching placebo were administered on a fixed flexible schedule beginning with 25 mg per day and adjusted up to 200 mg per day by week 8. Through week 8, subjects who were considered to be mildly ill or worse and who had minimal side effects were eligible for dose increases.

Psychiatrists and nurse clinicians with experience in medicating children with anxiety disorders were certified in the study pharmacotherapy protocol and received regular site-level and cross-site supervision.
Pill counts and medication diaries were used to facilitate and document adherence. Combination therapy consisted of the administration of sertraline and cognitive behavioral therapy. Whenever possible, therapy and medication sessions occurred on the same day for the convenience of subjects.

Objectives
Study objectives were, first, to compare the relative efficacy of the three active treatments with placebo; second, to compare combination therapy with either sertraline or cognitive behavioral therapy alone; and third, to assess the safety and tolerability of sertraline, as compared with placebo. We hypothesized that all three active treatments would be superior to placebo and that combination therapy would be superior to either sertraline or cognitive behavioral therapy alone.

Outcome Assessments
We obtained demographic information, information on symptoms of anxiety, and data on coexisting disorders and psychosocial functioning using reports from both the subjects and their parents and from interviews of subjects and parents at the time of screening, at baseline, and at weeks 4, 8, and 12.

The interviews were administered by independent evaluators who were unaware of study-group assignments.
We used the Anxiety Disorders Interview Schedule for DSM-IV-TR, Child Version,_20_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R20) to establish diagnostic eligibility. The categorical primary outcome was the treatment response at week 12, which was defined as a score of 1 (very much improved) or 2 (much improved) on the Clinical Global Impression Improvement scale,_21_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R21) which ranges from 1 to 7, with lower scores indicating more improvement, as compared with baseline. A score of 1 or 2 reflects a substantial, clinically meaningful improvement in anxiety severity and normal functioning. The dimensional primary
outcome was anxiety severity as measured on the Pediatric Anxiety Rating Scale, computed by the summation of six items assessing anxiety severity, frequency, distress, avoidance, and interference during the previous week._22_(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R22)

Total scores on this scale range from 0 to 30, with scores above 13 indicating clinically meaningful anxiety. The Children’s Global Assessment Scale_23_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R23) was used to rate
overall impairment.

Scores on this scale range from 1 to 100; scores of 60 or lower are considered to indicate a need for treatment, and a score of 50 corresponds to moderate impairment that affects most life situations and is readily observable. Agreement among the raters was high for anxiety severity (r=0.85) and diagnostic
status (intraclass correlation coefficient= 0.82 to 0.88) on the basis of a videotaped review of 10% of assessments by independent evaluators that were performed at baseline and at week 12.

Adverse Events
Adverse events were defined as any unfavorable change in the subjects’ pretreatment condition, regardless of its relationship to a particular therapy. Serious adverse events were life-threatening events, hospitalization, or events leading to major incapacity. Harm-related adverse events were defined as thoughts of harm to self or others or related behaviors. All subjects were interviewed at the start of each visit by the study coordinator with the use of a standardized script. Identified adverse events and harm-related events were then evaluated and rated by each subject’s study clinician.

This report presents data on all serious adverse events, all harm-related adverse events, andmoderate and severe (i.e., functionally impairing) adverse events that occurred in 3% or more of subjects in any study group. The data and safety monitoring board of the National Institute of Mental Health performed a quarterly review
of reported adverse events. Given the greater number of study visits (and hence more reporting
opportunities) and the unblinded administration of sertraline in the combination-therapy group, the test of the adverse-event profile of sertraline focused on statistical comparisons between sertraline and placebo and sertraline and cognitive behavioral therapy.

Randomization and Masking
The randomization sequence in a 2:2:2:1 ratio was determined by a computer-generated algorithm and maintained by the central pharmacy, with stratification according to age, sex, and study center. Subjects were assigned to study groups after being deemed eligible and undergoing verbal reconsent with a study investigator. Subjects in the sertraline and placebo groups did not know whether they were receiving active therapy, nor did their clinicians. However, subjects who received combination therapy knew they were receiving active sertraline. The study protocol called for independent evaluators who completed assessments to be unaware of all treatment assignments.

Statistical Analysis
On the basis of previous studies,_10_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R10) ,_11_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R11) ,_12_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R12)
,_13_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R13) ,_14_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R14) ,_15_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R15)
we hypothesized that 80% of children in the combination-therapy group, 60% in either the sertraline group
or the cognitive-behavioral-therapy group, and 30% in the placebo group would be considered to have had a response to treatment at week 12. We determined that we needed to enroll 136 subjects in each active-treatment group and 70 subjects in the placebo group for the study to have a power of 80% to detect a minimum difference of 17% between any two study groups in the rate of response, assuming an alpha of 0.05 and a two-tailed test with no adjustment for multiple comparisons.

Analyses were performed with the use of SAS software, version 9.1.3 (SAS Institute). For categorical outcomes (including data regarding adverse events), treatments were compared with the use of Pearson’s chi-square test, Fisher’s exact test, or logistic regression, as appropriate. Logistic-regression models included the study center as a covariate. For dimensional outcomes, linear mixed-effects models (implemented with the use of PROC MIXED) were used to determine predicted mean values at each assessment point (weeks 4, 8, and 12)
and to test the study hypotheses with respect to between-group differences at week 12.

In each linear mixed-effects model, time and study group were included as fixed effects, with linear and quadratic time and time-by-treatment group interaction terms. Each model also began with a limited number of covariates (e.g., age, sex, and race), followed by backward stepping to identify thebest-fitting and most parsimonious model. In all models, random effects included intercept and linear slope terms, and an unstructured covariance was used to account for within-subject correlation over time. All comparisons were planned and tests were two-sided. A P value of less than 0.05 was considered to indicate statistical significance. The sequential Dunnett test was used to control the overall (familywise) error rate._24_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R24)

We analyzed data from all subjects according to study group. Sensitivity analyses were performed with the last observation carried forward (LOCF) and multiple imputation assuming missingness at random. Results were similar for the two missing-data methods. We report the results of the LOCF analysis because the
response rates were lower and hence provide a more conservative estimate of outcomes.

Results
Subjects
A total of 3066 potentially eligible subjects were screened by telephone
(_Figure 1_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#F1) ). Of these subjects, 761 signed consent forms and completed the inclusion and exclusion evaluation, 524 were deemed to be eligible and completed the baseline assessment, and 488 underwent randomization. Eleven subjects (2.3%) stopped
treatment but were included in the assessment (treatment withdrawals); 46 subjects (9.4%) stopped both treatment and assessment (study withdrawals).

On the basis of logistic-regression analyses, pairwise comparisons indicated that subjects in the cognitive-behavioral-therapy group were significantly less likely to withdraw from treatment than were those in the sertraline group (odds ratio, 0.33; 95% confidence interval [CI], 0.13 to 0.87; P=0.03) or the placebo
group (odds ratio, 0.24; 95% CI; 0.09 to 0.67; P=0.006). Of the 488 subjects who underwent randomization, 459 (94.1%) completed at least one postbaseline assessment, 396 (81.1%) completed all four assessments, and 440 (90.2%) completed the assessment at week 12. Subjects were recruited primarily through advertisements (52.2%) or clinical referrals (44.1%).
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Figure 1. Enrollment and Outcomes.

Subjects who are shown as having withdrawn from treatment discontinued their assigned therapy but continued to undergo study assessment. Subjects who are shown as having withdrawn from the study discontinued both therapy and assessment. CBT denotes cognitive behavioral therapy.

Of 14 possible sessions of cognitive behavioral therapy, the mean (±SD) number of sessions completed was 12.7±2.8 in the combination-therapy group and 13.2±2.0 in the cognitive-behavioral-therapy group. The mean dose of sertraline at the final visit was 133.7±59.8 mg per day (range, 25 to 200) in the combination-therapy group, 146.0±60.8 mg per day (range, 25 to 200) in the sertraline group, and 175.8±43.7 mg per day (range, 50 to 200) in the placebo group.

Demographic and Clinical Characteristics
There were no significant differences among study groups with respect to baseline demographic and clinical characteristics (_Table 1_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#T1) ). The mean age of participants was 10.7±2.8 years, with 74.2% under the age of 13 years.

There were nearly equal numbers of male and female subjects. Most subjects were white (78.9%), with
other racial and ethnic groups represented. Subjects came from predominantly middle-class and upper-middle-class families (74.6%) and lived with both biologic parents (70.3%). Most subjects had received the diagnosis of two or more primary anxiety disorders (78.7%) and one or more secondary disorders
(55.3%). At baseline, subjects had moderate-to-severe anxiety and impairment (_Table
2_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#T2) ).

Given the geographic diversity among study centers, there were significant differences among sites on several baseline demographic variables (e.g., race and socioeconomic status). Overall, these variables were equally distributed among study groups within each center; however, three centers had one instance each of
unequal distribution for sex, race, or socioeconomic status.

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Table 1. Baseline Characteristics of the Subjects and Recruitment According
to Study Center.

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Table 2. Key Outcomes at 12 Weeks.

Clinical Response
In the intention-to-treat analysis, the percentages of children who were rated as 1 (very much improved) or 2 (much improved) on the Clinical Global Impression–Improvement scale at 12 weeks were 80.7% (95% CI, 73.3 to 86.4) in the combination-therapy group, 59.7% (95% CI, 51.4 to 67.5) in the cognitive-behavioral-therapy group, 54.9% (95% CI, 46.4 to 63.1) in the sertraline group, and
23.7% (95% CI, 15.5 to 34.5) in the placebo group (_Table 2_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#T2) ).

With the study center as a covariate, planned pairwise comparisons from a logistic-regression model showed
that each active treatment was superior to placebo as follows: combination therapy versus placebo, P<0.001 (odds ratio, 13.6; 95% CI, 6.9 to 26.8); cognitive behavioral therapy versus placebo, P<0.001 (odds ratio, 4.8; 95% CI, 2.6 to 9.0); and sertraline versus placebo, P<0.001 (odds ratio, 3.9; 95% CI, 2.1 to 7.4). Similar pairwise comparisons revealed that combination therapy was superior to either sertraline alone (odds ratio, 3.4; 95% CI, 2.0 to 5.9; P<0.001) or cognitive behavioral therapy alone (odds ratio, 2.8; 95% CI, 1.6 to 4.8; P=0.001). However, there was no significant difference between sertraline and cognitive behavioral therapy (P=0.41).

There was no main effect for center (P=0.69); however, a comparison among centers according to study group revealed a significant difference in response to combination therapy but no differences with respect to the response to sertraline alone (P=0.15) or cognitive behavioral therapy alone (P=0.25).

Further evaluation of response rates revealed that the average response rate for combination therapy at one center was significantly lower than at the other centers (P=0.002). A sensitivity analysis of site response rates showed that when data from the one site were removed, the average response rate of the other sites was consistent with that of the full sample.

The mixed-effects model for the Pediatric Anxiety Rating Scale revealed a significant quadratic effect for time (P<0.001) and a significant quadratic time-by-treatment interaction for cognitive behavioral therapy versus placebo (P=0.01) but not for either combination therapy or sertraline versus placebo. In other words, as compared with placebo, cognitive behavioral therapy had a linear mean trajectory (_Figure 2_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#F2) ). Planned pairwise comparisons of the expected mean scores on the Pediatric Anxiety Rating Scale at week 12 revealed a similar ordering of
outcomes, with all active treatments superior to placebo, according to the following comparisons: combination therapy versus placebo, t=–5.94 (P<0.001); cognitive behavioral therapy versus placebo, t=–2.11 (P=0.04); and sertraline versus placebo, t=–3.15 (P=0.002). In addition, combination therapy was
superior to both sertraline alone (t=–3.26, P=0.001) and cognitive behavioral therapy alone (t=–4.73, P<0.001). No significant difference was found between sertraline and cognitive behavioral therapy (t=1.32, P=0.19). The same magnitude and pattern of outcome was found for the Clinical Global Impressio Severity
scale and the Children’s Global Assessment Scale.
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Figure 2. Scores on the Pediatric Anxiety Rating Scale during the 12-Week
Study.

Scores on the Pediatric Anxiety Rating Scale range from 0 to 30, with scores higher than 13 consistent with moderate levels of anxiety and a diagnosis of an anxiety disorder. The expected mean score is the mean of the sampling distribution of the mean.

Estimates of the effect size (Hedges’ g) and the number needed to treatbetween the active-treatment groups and the placebo group were calculated. Effect sizes are based on the expected mean scores on the Pediatric Anxiety
Rating Scale, derived from the mixed-effects model. The number needed to treat is based on the dichotomized, end-of-treatment scores on the Clinical Global Impression–Improvement scale with the use of LOCF. The effect size was 0.86 (95% CI, 0.56 to 1.15) for combination therapy, 0.45 (95% CI, 0.17 to 0.74) for
sertraline, and 0.31 (95% CI, 0.02 to 0.59) for cognitive behavioral treatment.

The number needed to treat was 1.7 (95% CI, 1.7 to 1.9) for combination therapy, 3.2 (95% CI, 3.2 to 3.5) for sertraline, and 2.8 (95% CI, 2.7 to 3.0) for cognitive behavioral therapy. Treatment and Study Withdrawals
Most treatment and study withdrawals were attributed to reasons other than adverse events (43 of 57, 75.4%) (_Table 3_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#T3) ).

Of the 14 withdrawals that were attributed to an adverse event, 11 (78.6%) were in the groups receiving either sertraline alone or placebo and consisted of 3 physical events (headache, stomach pains, and tremor) and 8 psychiatric adverse events (worsening of symptoms, 3 subjects; agitation or disinhibition, 3; hyperactivity, 1; and nonsuicidal self-harm and homicidal ideation, 1).
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Table 3. Subjects Who Withdrew from Treatment or the Study.

Serious Adverse Events
Three subjects had serious adverse events during the study period. One child in the sertraline group had a worsening of behavior that was attributed to the parents’ increased limit setting on avoidance behavior; the event was considered to be possibly related to sertraline. A child in the combination-therapy
group had a worsening of preexisting oppositional defiant behavior that resulted in psychiatric hospitalization; this event was considered to be unrelated to a study treatment. The third subject was hospitalized for a tonsillectomy, which was also considered to be unrelated to a study treatment
(_Table
4_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#T4) ).
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Table 4. Moderate-to-Severe Adverse Events at 12 Weeks.

Adverse Events
Subjects in the combination-therapy group had a greater number of study visits and therefore significantly more opportunities for elicitation of adverse events than did those in the other study groups, with a mean of 12.8±4.0 opportunities (range, 1 to 22) in the combination-therapy group, as compared with 9.9±3.6 (range, 1 to 14) in the sertraline group, 10.6±2.0 (range, 1 to 14) in the cognitive-behavioral-therapy group, and 9.7±4.2 (range, 1 to 14) in the placebo group (P<0.001 for all comparisons). Rates of adverse events,
including suicidal and homicidal ideation, were not significantly greater in the sertraline group than in the placebo group. No child in the study attempted suicide. Among children in the cognitive-behavioral-therapy group, there were fewer reports of insomnia, fatigue, sedation, and restlessness or fidgeting than in the sertraline group (P<0.05 for all comparisons). For a list of mild adverse events that were not associated with functional impairment, as well as moderate and severe events, see the _Supplementary Appendix_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633/DC1) ,

available with the full text of this article at www.nejm.org.

Discussion
Our study examined therapies that many clinicians consider to be the most promising treatments for childhood anxiety disorders. Our findings indicate that as compared with placebo, the three active therapies combination therapy with both cognitive behavioral therapy and sertraline, cognitive behavioral therapy alone, and sertraline alone — are effective short-term treatments for children with separation and generalized anxiety disorders and social phobia, with combination treatment having superior response rates. No physical,psychiatric, or harm-related adverse events were reported more frequently in the sertraline group than in the placebo group, a finding similar to that for SSRIs, as identified in previous studies of anxious children._12_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R12) ,_13_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R13) ,_25_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R25)

Few withdrawals from either treatment or the study were attributed to adverse events. Suicidal ideation and homicidal ideation were uncommon. No child attempted suicide during the study period. Since they were recruited at multiple centers and locations, the study subjects were racially and ethnically diverse. However, despite intense outreach, the sample did not include the most socioeconomically disadvantaged children.
Subjects were predominantly younger children and included those with ADHD and other anxiety disorders, factors that allow for generalization of the results to these populations.

Conversely, the exclusion of children and teens with major depression and pervasive developmental disorders may have limited the generalizability of the results to these populations.The observed advantage of combination therapy over either cognitive behavioral therapy or sertraline alone during short-term treatment (an improvement of 21 to 25%) suggests that among these effective therapies, combination therapy
provides the best chance for a positive outcome. The superiority of combination therapy might be due to additive or synergistic effects of the two therapies. However, additional contact time in the combination-therapy group, which was unblinded, and expectancy effects on the part of both subjects and
clinicians cannot be ruled out as alternative explanations.

Nonetheless, the magnitude of the treatment effect in the combination-therapy group (with two
subjects as the number needed to treat to prevent one additional event) suggests that children with anxiety disorders who receive quality combination therapy can consistently expect a substantial reduction in the severity of anxiety. An increased number of visits in the combination-therapy group resulted in increased opportunities for elicitation of adverse events. Consequently, the potential for expectancies among subjects, parents, and clinicians regarding the side effects of medications in the context of more visits may have increased the rate of some adverse events in the combination-therapy group and may limit conclusions that can be drawn regarding the rates of adverse events in combination therapy.

The positive benefit of cognitive behavioral therapy, as compared with placebo, adds new information to the existing literature._26_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R26)
The number needed to treat for cognitive behavioral therapy in this study (three subjects) is the same as that
identified in a meta-analysis of studies comparing subjects who were assigned to cognitive behavioral therapy with those assigned to a waiting list for therapy or to sessions without active therapy._14_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R14)

Our study’s test of cognitive behavioral therapy included children with moderate-to-severe anxiety and addresses criticism of previous trials that included children with only mild-to-moderate
anxiety._14_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R14)
Before our study, cognitive behavioral therapy for childhood anxiety was considered to be
“probably efficacious.”_26_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R26)

This evaluation of cognitive behavioral therapy and other recent studies_27_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R27)
,_28_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R28) suggests that
such therapy for childhood anxiety is a well-established, evidenced-based treatment._29_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R29)

Given that the risk of some adverse events was lower in the behavioral-therapy group than in the sertraline group, some parents and their children may consider choosing cognitive behavioral therapy as their initial treatment.

The results of our study confirm the short-term efficacy of sertraline for children with generalized anxiety disorder_25_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R25) and show that
sertraline is effective for children with separation anxiety disorder and social phobia. The number needed
to treat for sertraline in our study (three subjects) was the same as that previously identified in a meta-analysis_15_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R15) of six
randomized, placebo-controlled trials of SSRIs for childhood anxiety disorders._12_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R12) ,_13_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R13) ,_25_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R25)
,_30_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R30) ,_31_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R31)

These studies and others_27_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R27)
suggest that SSRIs, as a class, are the medication of choice for these conditions. The titration schedule that we used, which emphasized upward dose adjustment in the absence of response and adverse events, suggests that the average end-point dose of sertraline in this study is the highest dose consistent with good outcome and tolerability. No adverse events were observed more frequently in the sertraline group than in the placebo group. In contrast to the apparent risk of suicidal ideation and behavior in studies of depression in children and
adolescents,_15_ (http://content.nejm.org/cgi/content/full/NEJMoa0804633#R15) our study did not demonstrate any increased risk for suicidal behavior in the sertraline group. Given the benefit of sertraline alone or in combination with cognitive behavioral therapy and the limited risk of adverse events associated with the drug in our study, the well-monitored use of sertraline and other SSRIs in the treatment of childhood anxiety disorders is indicated.

Cognitive behavioral therapy and sertraline either in combination or as monotherapies appear to be effective treatments for these commonly occurring childhood anxiety disorders. Results confirm those of previous studies of SSRIs and cognitive behavioral therapy and, most important, show that combination
therapy offers children the best chance for a positive outcome. Our findings indicate that all three of the treatment options may be recommended, taking into consideration the family’s treatment preferences, treatment availability, cost, and time burden. To inform more prescriptive selection of patients for
treatment, further analysis of predictors and moderators of treatment response may identify who is most likely to respond to which_32_
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#R32) of these
effective alternatives.
Supported by grants (U01 MH064089, to Dr. Walkup; U01 MH64092, to Dr.
Albano; U01 MH64003, to Dr. Birmaher; U01 MH63747, to Dr. Kendall; U01 MH64107,
to Dr. March; U01 MH64088, to Dr. Piacentini; and U01 MH064003, to Dr. Compton)
from the National Institute of Mental Health (NIMH).

Sertraline and matching placebo were supplied free of charge by Pfizer. Dr. Walkup reports receiving consulting fees from Eli Lilly and Jazz Pharmaceuticals and fees for legal consultation to defense counsel and
submission of written reports in litigation involving GlaxoSmithKline, receiving lecture fees from CMP Media, Medical Education Reviews, McMahon Group, and DiMedix, and receiving support in the form of free medication and matching placebo from Eli Lilly and free medication from Abbott for clinical trials funded by the NIMH; Dr. Albano, receiving royalties from Oxford University Press for the Anxiety Disorders Interview Schedule for DSM-IV, Child and Parent Versions, but not for interviews used in this study, and royalties from the Guilford Press; Dr. Piacentini, receiving royalties from Oxford University Press for treatmentmanuals on childhood obsessive compulsive disorder and tic disorders and from the Guilford Press and APA Books for other books on child mental health and receiving lecture fees from Janssen-Cilag; Dr. Birmaher, receiving consulting fees from Jazz Pharmaceuticals, Solvay Pharmaceuticals, and Abcomm, lecture fees from Solvay, and royalties from Random House for a book on children with bipolar disorder; Dr. Rynn, receiving grant support from Neuropharm, BoehringerIngelheim Pharmaceuticals, and Wyeth Pharmaceuticals, consulting fees from Wyeth, and royalties from APPI for a book chapter on pediatric anxiety disorders; Dr. McCracken, receiving consulting fees from Sanofi-Aventis and Wyeth, lecture fees from Shire and UCB, and grant support from Aspect, Johnson & Johnson, Bristol-Myers Squibb, and Eli Lilly; Dr. Waslick, receiving grant support from Baystate Health, Somerset Pharmaceuticals, and GlaxoSmithKline; Dr. Iyengar, receiving consulting fees from Westinghouse for statistical consultation; Dr. March, receiving study medications from Eli Lilly for an NIMH-funded clinical trial and receiving royalties from Pearson for being the author of the Multidimensional Anxiety Scale for Children, receiving consulting fees from Eli Lilly, Pfizer, Wyeth, and GlaxoSmithKline, having an equity interest in MedAvante, and serving on an advisory board for AstraZeneca and Johnson & Johnson; and Dr. Kendall, receiving royalties from Workbook Publishing for anxiety-treatment materials.

No other potential conflict of interest relevant to this article was reported.

The views expressed in this article are those of the authors and do not necessarily represent the official views of the NIMH, the National Institutes of Health, or the Department of Health and Human Services.
We thank the children and their families who made this study possible; and J. Chisar, J. Fried, R. Klein, E. Menvielle, S. Olin, J. Severe, D. Almirall, and members of NIMH’s data and safety monitoring board.
* The study investigators are listed in the Appendix.
(http://content.nejm.org/cgi/content/full/NEJMoa0804633#RFN1)

Source Information
From the Johns Hopkins Medical Institutions, Baltimore (J.T.W., G.S.G.); New York State Psychiatric Institute–Columbia University Medical Center, New York (A.M.A., M.A.R.); the University of California at Los Angeles, Los Angeles (J.P., J.M.); Western Psychiatric Institute and Clinic University of Pittsburgh Medical Center, Pittsburgh (B.B., S.I.); Duke University Medical Center, Durham, NC (S.N.C., J.S.M.); the Division of Services and Intervention Research, National Institute of Mental Health, Bethesda, MD (J.T.S.); Baystate
Medical Center, Springfield, MA (B.W.); and Temple University, Philadelphia
(P.C.K.).

This article (10.1056/NEJMoa0804633) was published at www.nejm.org on
October 30, 2008. It will appear in the December 25 issue of the Journal.
Address reprint requests to Dr. Walkup at the Division of Child and
Adolescent Psychiatry, Department of Psychiatry and Behavioral Sciences, Johns
Hopkins Medical Institutions, 600 N. Wolfe St., Baltimore, MD 21287.
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Appendix
The following investigators participated in this study: Steering Committee:
J. Walkup (chair), A. Albano (cochair); Statistics–Experimental Design: S.
Compton, S. Iyengar, J. March; Cognitive Behavioral Therapy: P. Kendall, G.
Ginsburg; Pharmacotherapy: M. Rynn, J. McCracken; Assessment: J. Piacentini,
A. Albano; Study Coordinators: C. Keeton, H. Koo, S. Aschenbrand, L. Bardsley,
R. Beidas, J. Catena, K. Dever, K. Drake, R. Dublin, E. Fontaine, J. Furr, A.
Gonzalez, K. Hedtke, L. Hunt, M. Keller, J. Kingery, A. Krain, K. Miller, J.
Podell, P. Rentas, M. Rozenmann, C. Suveg, C. Weiner, M. Wilson, T. Zoulas;
Data Center: M. Fletcher, K. Sullivan; Cognitive Behavior Therapists: E.
Gosch, C. Alfano, A. Angelosante, S. Aschenbrand, A. Barmish, L. Bergman, S.
Best, J. Comer, S. Compton, W. Copeland, M. Cwik, M. Desari, K. Drake, E.
Fontaine, J. Furr, P. Gammon, C. Gaze, R. Grover, H. Harmon, A. Hughes, K.
Hutchinson, J. Jones, C. Keeton, H. Kepley, J. Kingery, A. Krain, A. Langley,
J. Lee, J. Levitt, J. Manetti-Cusa, E. Martin, C. Mauro, K. McKnight, T. Peris, K.
Poling, L. Preuss, A. Puliafico, J. Robin, T. Roblek, J. Samson, M.
Schlossberg, M. Sweeney, C. Suveg, O. Velting, T. Verduin; Pharmacotherapists:
M. Rynn, J. McCracken, A. Adegbola, P. Ambrosini, D. Axelson, S. Barnett, A. Baskina,
B. Birmaher, C. Cagande, A. Chrisman, B. Chung, H. Courvoisie, B. Dave, A.
Desai, K. Dever, M. Gazzola, E. Harris, G. Hirsh, V. Howells, L. Hsu, I.
Hypolite, F. Kampmeier, S. Khalid-Khan, B. Kim, D. Kondo, L. Kotler, M.
Krushelnycky, J. Larson, J. Lee, P. Lee, C. Lopez, L. Maayan, J. McCracken, R.
Means,L. Miller, A. Parr, C. Pataki, C. Peterson, P. Pilania, R. Pizarro, H. Ravi,
S. Reinblatt, M. Riddle, M. Rodowski, D. Sakolsky, A. Scharko, R. Suddath, C.
Suarez, J. Walkup, B. Waslick; Independent Evaluators: A. Albano, G.
Ginsburg, B. Asche, A. Barmish, M. Beaudry, S. Chang, M. Choudhury, B. Chu, S.
Crawley, J. Curry, G. Danner, N. Deily, R. Dingfelder, D. Fitzgerald, P.
Gammon, S. Hofflich, E. Kastelic, J. Keener, T. Lipani, K. Lukin, M. Masarik, T.
Peris, T. Piacentini, S. Pimentel, A. Puliafico, T. Roblek, M. Schlossberg, E.
Sood, S. Tiwari, J. Trachtenberg, P. van de Velde; Pharmacy: K. Truelove, H.
Kim; Research Assistants: S. Allard, S. Avny, D. Beckmann, C. Brice, B.
Buzzella, E. Capelli, A. Chiu, M. Coles, J. Freeman, M. Gringle, S. Hefton, D.
Hood, M. Jacoby, J. King, A. Kolos, B. Lourea-Wadell, L. Lu, J. Lusky, R. Maid, C.
Merolli, Y. Ojo, A. Pearlman, J. Regan, S. Rock, M. Rooney, N. Simone, S.
Tiwari, S. Yeager.

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